FDA
Further US approval for Xarelto
November 5, 2012Sales and Marketing Eliquis, FDA, Pradaxa, Xarelto
US regulators have given the go-ahead to expand the indications for which Janssen Pharmaceuticals and Bayer HealthCare’s oral blood thinner …
Teva’s CML drug approved
October 29, 2012Research and Development, Sales and Marketing FDA, Synribo, Teva
Teva’s new treatment for chronic myeloid leukemia Synribo has been approved by the FDA. Synribo (omacetaxine mepesuccinate) is an injectable …
Contaminated steroids blamed for deadly meningitis outbreak
October 25, 2012Manufacturing and Production FDA, GMP, NECC
As many as 14,000 patients may have been exposed to contaminated steriods that have led to 23 deaths due to …
FDA committee recommends Kynamro
October 23, 2012Research and Development, Sales and Marketing FDA, Genzyme, Kynamro, Sanofi
Sanofi’s anti-cholestrol drug Kynamro has been recommended by an FDA committee, paving the way for US approval early next year. …
FDA approves Bayer’s Stivarga
October 1, 2012Research and Development, Sales and Marketing Bayer, FDA, KRAS, Roche, Stivarga, avastin
The FDA has approved Bayer HealthCare’s oncology pill Stivarga to treat patients with metastatic colorectal cancer (mCRC) whose disease has …
New quad HIV pill passed by FDA
September 2, 2012Sales and Marketing FDA, Gilead, HIV, stribild
Gilead’s four-in-one anti-HIV once-daily pill Stribild has been given the green light by the FDA for adults who have not …
GMP certification bodes well for Alexza’s lead product
August 28, 2012Manufacturing and Production Alexza, FDA, GMP, schizophrenia
US drugmaker Alexza Pharmaceuticals’ manufacturing facility for lead product Adasuve has been given a green light from the Spanish medicine …
Pfizer’s arthritis drug delayed by FDA
August 21, 2012Research and Development, Sales and Marketing FDA, Pfizer, tofacitinib
Pfizer says its new rheumatoid arthritis drug tofacitinib has been delayed by the FDA. Tofacitinib, an oral Janus kinase (JAK) …
Claris LifeSciences gets clean bill of health from FDA
August 20, 2012Manufacturing and Production, Sales and Marketing Claris, FDA, Pfizer, sterile
Indian drugmaker Claris LifeSciences seems to have set its house in order after manufacturing issues led the FDA to impose …
Novartis eye drug succeeds in Phase III trial
August 16, 2012Sales and Marketing FDA, Novartis, Ocriplasmin, Roche, VMA
Novartis has posted positive results for its investigational eye drug ocriplasmin. The Phase III study found that ocriplasmin significantly resolved …
Pfizer pays $250m for OTC Nexium rights
August 14, 2012Sales and Marketing AstraZeneca, EMA, FDA, Nexium, OTC, Pfizer
Pfizer will pay $250 million to AstraZeneca in order to gain the rights to sell an over-the-counter form of the …
Lucentis gains new licence in the US
August 13, 2012Sales and Marketing Eylea, FDA, Lucentis, approval, avastin, wet AMD
Roche’s eye drug Lucentis has gained a new licence in the US to treat diabetic macular oedema. The FDA has …
FDA approves leukaemia drug Marqibo
August 10, 2012Sales and Marketing FDA, Marqibo, Talon Therapeutics, lilly
The Food and Drug Administration has given the green light for Talon Therapeutics’ Marqibo to combat a rare form of …
Pfizer pays $60m in bribery cases
August 8, 2012Sales and Marketing DoJ, FDA, GSK, Janssen, Pfizer, Wyeth, bribery
Pfizer has been fined $60 million for making improper payments to doctors in Europe, Asia and the Middle East. The …
Champix better than patches for smoking cessation
August 7, 2012Sales and Marketing Champix, FDA, Pfizer, Zyban, smoking
New research shows that Pfizer’s Champix is better than nicotine patch therapy at helping smokers kick the habit. A Pfizer …
